In a packed hearing room at the Food and Drug Administration last week, a panel of cardiac experts met to consider what was obviously an important question: Has one of the most popular treatments for heart disease in fact been killing some of the patients it is meant to help?
Three years ago, doctors began using a new device called a drug-coated stent — a tiny metal tube — to keep blocked heart arteries open. It cost a lot more than an uncoated stent, but because it seemed to be far more effective, it quickly began to dominate the stent market. Last year, Johnson & Johnson and Boston Scientific together sold more than one million drug-coated stents. They have become a primary treatment for this country’s No. 1 cause of death.
In recent months, though, researchers found a disturbing pattern. People with a drug-coated stent seemed unusually vulnerable to blood clots in later years. The new stents solved one problem, but they may have created another. So the F.D.A. summoned its cardiology advisers to review the evidence.
After listening to testimony, they concluded that for healthier patients with simple forms of heart disease, the benefits of drug-coated stents appeared to outweigh the risks. The picture was less clear for people with diabetes, multiple blocked arteries or other complications. In the end, the panel concluded that doctors and patients needed to be aware of the risks and that researchers should continue collecting data. The entire affair — from the invention of the new stent to the willingness to reconsider it — was in many ways an impressive display of American medicine.
Yet it was also a nearly perfect example of what’s wrong with our health care system.
See, there was an elephant in the hearing room last week that went almost entirely ignored. One study after another has found that whether or not a stent is coated, angioplasty — the process of opening up an artery before a stent is inserted — and stenting do not actually reduce the risk of heart attack or extend life span for most patients.
“There’s a much more liberal use of angioplasty and stenting than there needs to be,” Dr. Eric J. Topol, a member of the panel, told me last week.
Dr. Calvin L. Weisberger, the top cardiologist at Kaiser Permanente, said, “A large pool of angioplasties and bypass surgeries are being done without scientific evidence.”
The problem is that there’s nobody whose job it is to say no. The F.D.A. steps in when there are safety concerns. But no federal agency or medical group takes action when an expensive form of treatment becomes far more common than it needs to be — which is a big reason that health care spending is rising so rapidly.
Angioplasty dates back to the 1970s, and stents became a part of the process in the 1990s. Doctors have assumed, sensibly enough, that blocked arteries caused heart attacks by preventing blood from reaching the heart. Opening those arteries would keep the blood flowing.
But when researchers tried to prove the theory, they kept coming up empty. The reason seems to be that heart attacks aren’t generally caused by a big buildup of plaque that blocks an artery. They occur instead when a small piece of plaque bursts, causing a cascade that can suddenly clog an open artery. The best way to reduce the risk of that is through cholesterol-lowering drugs, diet and exercise, rather than by opening up a couple of clogged arteries.
Yet stent use keeps growing. “Cardiologists just believe that if you open up a blockage, you’re going to help someone,” said Dr. Judith S. Hochman, director of the cardiovascular clinical research center at New York University. “And they make money from these procedures.”
Ah, yes — money. Medicare typically pays $12,000 to $15,000 for a coated stent procedure, according to Thomas Gunderson of Piper Jaffray. Angioplasty and stenting have accounted for almost 10 percent of the increase in Medicare spending since the mid-1990s, Jonathan S. Skinner, a Dartmouth economist, estimates.
As I’ve written before, we sometimes worry too much about medical spending. An affluent society should devote an ever-growing share of its resources to health care. And stents can be a wonderful thing. They greatly benefit people if implanted during a heart attack or soon after, research has found, by getting blood moving again. They can also reduce chest pain in heart disease patients who have angina, which is no small thing.
But that still leaves a large number of patients — those without symptoms and those who had a heart attack several days earlier — receiving a stent for little reason. Dr. Topol said he thought these cases could add up to 20 percent of all procedures.
Dr. David D. Waters, a cardiologist at the University of California, San Francisco, said one study found the angioplasty rate to be twice as high among a group of American patients as it was among a group of Canadians. But the Americans didn’t have better survival rates and had only somewhat less angina.
Economic incentives for doctors (including their paychecks and their fear of lawsuits) to choose the most aggressive treatment certainly play a big role. At Kaiser, where doctors tend to be paid a set salary regardless of which procedures they do, angioplasty rates are lower.
But we patients deserve some of the blame, too. We’ve come to believe that aggressive treatment somehow offers us the best chance to stay healthy, even when the evidence says otherwise. “This is a society that demands that everything that can conceivably be tested or done or fixed should be,” Dr. Hochman said. “Other cultures are not like that.”
That’s why fixing the health care system is going to be difficult. To save real money, reform can’t simply be about taking profits away from doctors or insurers. It will also have to involve an acknowledgment that, sometimes, Medicare or an insurance policy should nudge people away from the latest, greatest treatment.
I don’t mean to suggest that decisions about stenting are easy. No two patients are the same, and it’s possible that future research will help in understanding who benefits from a stent and who doesn’t. For now, though, maybe one way to spend less money on heart care is to stop thinking about the money.
We know there is a large group of patients who do not seem to be helped by angioplasty. We also know that while the procedure is usually safe, complications from it still probably kill a few thousand Americans every year.
As Dr. Weisberger says he tells his patients: “There’s risk. You don’t want to do this for nothing.”
